PATHFAST cTnI

by PHC Corporation Japan EUDAMED

Ref 30111

EMDN W01021306

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number4987595PF1011KWS Basic UDI-DI	Date29 May 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

V76 123901 0007 Issued

Technical documentation EU IVDR

Notified body

TÜV SÜD Product Service GmbH 0123

Issued
5 Jun 2026

Expires
28 Feb 2028

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference: 30111

Primary DI / UDI-DI: 04987595301117
Basic UDI-DI: 4987595PF1011KWS
EMDN Code: W01021306 Troponin i/t

Device Class: Class C
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: JP-MF-000008516
Authorised representative: PHC Europe B.V. NL-AR-000002692

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Properties & raw data

Show properties, registry sources and raw records

Human Tissues
Animal Tissues
Reagent
Near-Patient Testing
Professional Testing

Other properties (6)

Sterile: No
Microbial Substances: No
Self Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No

Sources (1)

EUDAMED 04987595301117|4987595PF1011KWS 61 fields · synced 24 Oct 2026